Device for applying liquid medical substances

ABSTRACT

A device (1) for the application of liquid medical substances (100) comprises a main body (2) extending around a longitudinal axis (X) and comprising a housing portion (3) at a first open end (4) and a delivery portion (5) at a second open end (6) which is opposite the first (4); a hermetically sealed cartridge reservoir (7) containing a liquid medical substance (100); a perforating element (8) disposed inside the main body (2) in a position falling between the housing portion (3) and the delivery portion (5) and such as to achieve the perforation of one end of the cartridge reservoir (7). The perforating element (8) has a tubular shape and comprises, in a central portion thereof, a cylindrical conduit (12) having a cutting edge (14) faced towards the housing portion (3).

TECHNICAL FIELD

The present invention relates to a device for the application of liquidmedical substances.

In particular, the present device has particular application in therealm of medical care, in hospital or health facilities or mobile firstaid stations, during situations of emergency or of simple medical careprovided by specialized personnel to people who need liquid medicalsubstances to be applied on the skin and in practices related to thepreoperative preparation of skin.

In particular, according to the technical field in which the presentinvention falls, the applicator device mainly delivers liquid medicalsubstances, such as antiseptic and/or disinfectant substances based onchemical components and suitable for treating a person's skin, hence forexternal use.

Such applicator devices are generally of the disposable type, and thusdelivery of the liquid substance is possible only once after the deviceis activated, until the liquid runs out and/or the pad dries. This is anecessary condition for ensuring the aseptic characteristics of the pad.

PRIOR ART

The device generally includes a main body, preferably extendinglongitudinally along an axis and housing within it a reservoircontaining the medical liquid, sealed by means of a cap. The reservoircan be inserted into the cylindrical body either by sliding it linearlyor screwing it around the longitudinal axis.

The cylindrical body generally also defines the handgrip of the deviceitself for use.

At one end of the cylindrical body, the device has a pad, composed of anabsorbent element such as, for example, a natural fabric or spongyelements, for applying the medical substance on the patient's skin.

In an intermediate position between the reservoir and the applicator padthere is a perforating element which serves to tear open the closure capof the reservoir upon need and permit the discharge of the liquid, whichthus impregnates the pad.

The perforating element has a cutting portion capable of breaking theupper wall of the cap; the thickness of the wall depends on the materialof the cap and the dimensions concerned, but it must generally enableperforation by means of a simple manual gesture which can also becarried out by a person normally not assigned to use the device.

The perforating element is generally placed parallel to the axis of thedevice, in a coaxial or decentred position relative to the cap of thereservoir itself. Generally, the coaxial position is used when thecoupling between the reservoir and perforating element, and hence theactivation of the device, is achieved by axially sliding the reservoirinto the cylindrical body, whereas the lateral position is used when thecoupling between the reservoir and perforating element is achieved byrotating the reservoir around the longitudinal axis of the cylindricalbody. In the case of axial coupling, the perforating element includes acentral tip, from which cutting profiles extend radially and partiallyin an axial direction, and is connected to the cylindrical body by meansof fastening tabs that support it and keep it in position.

Alternatively, if the coupling is of the rotational type, theperforating element can simply be composed of a pointed spike placed inproximity to an interior wall of the cylindrical body and serving toachieve a progressive tearing along a circular line in the cap of thereservoir during rotation of the latter at the time the device isactivated.

With reference to the centrally located perforating element, it occupiesthe entire internal cross section of the torn cap, so the liquid flowsout around the tip in the space remaining between the cutting profiles,alternating with the fastening tabs, and the cylindrical body. Thisspace defines peripheral outflow channels along which the fluid flows.

Based on what is described above, the blade-like portions and radialsupporting extensions are angularly distributed around the axis.

According to the prior art, the perforating element is made in one piecewith the cylindrical body, and thus it has the same characteristics asthe material both are made of.

With respect to the method of use of the device, it should be specifiedthat, under normal storage conditions of the device, the reservoir isalready partially or entirely inserted into the cylindrical body andheld in a provisional locking position typical of the device's storageprior to its activation and actual use.

In particular, the storage position provides for a certain distancebetween the sealed side of the reservoir and the perforating elementdesigned to open it.

In the prior art, activation takes place as a result of a completeinsertion of the reservoir into the main body, which causes the breakageof the reservoir cap by means of the perforating element, thus releasingthe medical liquid toward the applicator pad through the aforementionedpassage channels.

In the prior art, the main body at the end accommodating the pad has alarger cross section precisely in order to have a greater surface extentof the pad to ensure adequate delivery of the medical liquid.

The known applicator device described above is such as not to beeffective under typical operational conditions of use because it showsseveral disadvantages and nonconformities compared to the correct use inthe “clean” practice of the above-described applications.

One may observe, in fact, scant control over the delivery of the medicalliquid contained in it, in terms of both quantity and delivery time andin terms of the handling and application of said quantity released onthe area to be treated. These disadvantages preclude correct performanceof the operating procedures related to the applications described in thepresent invention.

In other words, the known applicator device has a flow of liquid, duringactivation, which is not adequately calibrated on the basis of theactual size of the pad, and thus of the skin surface to be treatedwithin a certain time. In particular, irrespective of the pad size, andthus of the skin surface or area to be treated, situations can occur inwhich the pad is impregnated too little or too much. Such situations cancause risks and problems both for the health personnel and for thepatient being treated. Inadequate impregnation can cause an incorrectand/or insufficient application of the medical substance; just asexcessive soaking can cause the dispersal of the medical substanceoutside the skin area to be treated and an application time that isshorter than the minimum necessary based on the characteristics of themedical substance to be applied. In order to favour the outflow of thesubstance from the reservoir, the known applicator device requires amanual intervention of health personnel, the flow itself being hinderedby the perforating element and/or residues of the cap. This interventiongenerally consists in dabbing the device with vertical movements (effectsimilar to that of a volumetric pump which facilitates the suction of afluid) on the part of skin to be treated until complete delivery. Thispractice presents significant negative aspects and risks when it comesto medical applications, since it does not permit the medical substanceto be applied under complete asepsis for health personnel. The knownapplicator device is thus not suitable for use in a professionalsetting, in particular for preoperative preparation of the skin, or infirst aid situations, since availability and speed of delivery representessential requirements, together with use under complete asepsis forhealth personnel.

Furthermore, the known applicator device is such as to provoke,immediately after its activation by health personnel, involuntary andcounterproductive outward dispersions of the medical liquid.

These negative factors are mainly ascribable to the perforation anddelivery system provided for during activation of the device.

In fact, the tip part designed to open the reservoir tears open theupper wall of the cap in a not very effective manner, such as not topermit an adequate flow to be delivered and the flow is moreoverirregular and uneven.

The unsuitable configuration of the perforating element obstructs theoutflow from the reservoir, said element being positioned right at thecentre of the opening made by it, as well as diverting part of the flowof liquid into a peripheral zone non directly facing the pad. The tornparts of the cap lying in the internal part of the container continue torest on the perforating element and constitute a further element ofobstruction to the smooth passage of the liquid.

Moreover, the play necessarily provided for between the diameter of thereservoir and the inner diameter of the cylindrical body (to enable thereservoir to be conveniently pushed by hand) can cause involuntary leaksof the liquid into the gap created between the reservoir and thecylindrical body for the following reason.

In fact, when the device is activated, the upper edge of the reservoir,i.e. the one with the torn closure cap, does not arrive completely incontact with the base of the pad due to the presence of the fasteningtabs: this creates a space through which the liquid flowing out can leakand then run along the aforesaid gap if the device is repositionedvertically, with the pad turned upward.

The above-described effect is worsened further if the device must beused in an upright position with the pad positioned at the top: in thiscase, since in a first step the device must be maintained with the padturned down to facilitate the impregnation thereof, when the device isturned with the pad up, the medical liquid remaining in the gap can leakout, wetting the handgrip of the device, parts of areas not undergoingtreatment and health personnel. For this reason, even when not providedfor under the first aid protocol, health personnel should wear steriledisposable protective gloves in order to prevent any contagioustransmission to and from the skin.

OBJECT OF THE INVENTION

In this context, the technical task of the present invention is toprovide a device for the application of liquid medical substances whichis free of the above-mentioned drawbacks.

In particular, it is an object of the present invention to provide adevice for the application of liquid medical substances which makes itpossible to obtain, under completely aseptic and safe conditions, arapid delivery and, simultaneously, an outflow at a dosage that iscalibrated in terms of flow rate (i.e. ml/s), based on the type ofmedical liquid delivered onto the pad and the use thereof.

It is a further object of the present invention to provide a device forthe application of liquid medical substances which makes it possible toachieve an application on skin at a level of quality and safety for thehealth personnel and the patient that is higher than what is presentlypossible in the prior art and is above all obtainable under alloperational conditions of use of the device itself.

These and other objects are substantially achieved by a device for theapplication of liquid medical substances according to what is describedin one or more of the appended claims.

The dependent claims correspond to further embodiments of a device forthe application of liquid medical substances according to the presentinvention.

Additional features and advantages will be more clearly apparent fromthe detailed description of a preferred but non-exclusive embodiment ofa device for the application of liquid medical substances according tothe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

This description is provided with reference to the appended figures,which likewise have purely illustrative purposes and are thusnon-limiting, in which:

FIG. 1A is a perspective view of a device for the application of liquidmedical substances in accordance with the present invention, in anoperational condition in which the device is not activated;

FIG. 1B is a sectional side view of the device for the application ofliquid medical substances illustrated in FIG. 1A;

FIG. 2A is a perspective view of a device for the application of liquidmedical substances in accordance with the present invention, in anoperational condition in which the device is activated;

FIG. 2B is a sectional side view of the device for the application ofliquid medical substances illustrated in FIG. 2A;

FIG. 3 is a sectional plan view of the device for the application ofliquid medical substances, in accordance with the present invention;

FIG. 4 illustrates an exploded view of the device for the application ofliquid medical substances according to the present invention;

FIGS. 5a and 5b each represent a sectional side view of the device forthe application of liquid medical substances to which the presentinvention relates, in accordance with a second embodiment, in anon-operational and operational condition, respectively;

FIGS. 6a and 6b each represent a sectional side view of the device forthe application of liquid medical substances to which the presentinvention relates according to a third embodiment, in a non-operationaland operational condition, respectively.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

With reference to the appended figures, 1 indicates overall a device forthe application of a liquid medical substance according to the presentinvention.

In the preferred embodiment, illustrated in the appended figures, thedevice 1 comprises a main body 2, which extends around and along alongitudinal axis X, comprising a housing portion 3, at a first open end4, and a delivery portion 5, at a second open end 6, which is oppositethe first.

The device 1 further comprises a hermetically sealed cartridge reservoir7 containing a liquid medical substance 100, which is at an openable end7 a and adapted for being inserted inside the housing portion 3. Theopenable end 7 a of the reservoir 7 is the one that is completelyinserted inside the housing portion 3.

Advantageously, the coupling between the reservoir 7 and housing portion3 of the main body 2 takes place by sliding along the axis X. However,it is also possible to envisage, according to an unillustratedalternative configuration, a rotational type of coupling, i.e. achievedby screwing the reservoir 7 around the axis X inside the housing portion3, which, in such a case, will be threaded accordingly.

There is a perforating element 8 disposed inside the main body 2, in aposition falling between the housing portion 3 and the delivery portion5.

The perforating element 8, described in detail further below, is theelement used to open the reservoir 7 at the aforesaid sealed openableend 7 a. This is achieved by pressing the reservoir 7 inside the housingportion 3 until tearing open the aforesaid sealed openable end 7 a as aresult of the pressure on the latter by the perforating element 8.

Advantageously, the perforating element 8 has an internally hollowtubular shape and comprises a cylindrical conduit 12 extending away froma flanged annular base 13, adjacent to the delivery portion 5, towardthe housing portion 3.

In other words, the perforating element 8 has, at one of its ends, aflanged annular base 13 for connecting it with the main body 2; theperforating element 8 projects from the base 13 toward the housingportion 3 of the reservoir 7.

Preferably, the cylindrical conduit 12 also has a circular or oval crosssection, having an outer diameter d1 comprised between 3 and 15 mm,preferably between 5 and 10 mm, even more preferably between 7 and 9 mm.The cylindrical conduit 12 can be coaxial with the axis X or bedecentred.

Moreover, the cylindrical conduit 12 has a small wall thickness 12 a,preferably comprised between 1-2 mm.

At its free end, opposite the one connected to the base 13, thecylindrical conduit 12 has a cutting edge 14, turned toward the housingportion 3.

The conduit 12 serves to place the housing portion 3 in fluidcommunication with the delivery portion 5, and hence the reservoir 7 influid communication with the delivery portion 5 once the device isactivated.

The base 13 separates the delivery portion 5 from the housing portion 3.Preferably, the base 13 of the perforating element 8 has the samesection as the housing portion 3, and is thus in the shape of a closedcircular ring disposed around the cylindrical conduit 12. Furthermore,the annular base 13 is preferably coaxial with the longitudinal axis Xand preferably lies in a plane perpendicular to the axis X.

Advantageously, the base 13 is suitable for receiving, in a supportrelationship, the end 7 a of the reservoir 7 which is torn open by theperforating element 8.

Advantageously, the cutting edge 14 of the cylindrical conduit 12extends along a closed line which delimits, at least partially, theconduit 12.

Advantageously, the cutting edge 14 lies in an inclined plane, lendingthe conduit 12 the shape of a circular cylinder with a slanted cut atthe end corresponding to the cutting edge 14 itself, as illustrated inFIGS. 1A and 2A.

Preferably, the inclination of the aforesaid plane in which the cuttingedge 14 lies in is comprised between 30° and 60°, preferably equal to anangle α of 45° relative to the longitudinal axis X.

In addition, being one end of the wall 12 a of the cylindrical conduit12, the cutting edge 14 has the same thickness as the wall 12 a or, atmost, a blade-like tapered profile.

The main body 2 represents a basic element of the device 1, preciselybecause of its specific geometric and dimensional features, which makeit the element in which and on which the device 1 is assembled andcompleted during a production step.

Preferably, the main body 1 has an axisymmetric shape, in which thehousing portion 3 has a curvilinear cross section, preferably circularor elliptical, is hollow on the inside and communicates with the outside200. The delivery portion 5 can also have an axisymmetric shape with acurvilinear, preferably circular or elliptical, or polygonal crosssection.

In an alternative configuration, the reservoir 7 and the main body 2 canalso have a cylindrical shape with a polygonal cross section.

The housing portion 3 is designed to contain the cartridge reservoir 7for nearly the whole length of the housing portion 3 itself.

Preferably, the housing portion 3 also extends longitudinally in such away as also to ensure, simultaneously with what has been describedabove, a comfortable, secure grip during use of the device 1.

In particular, the housing portion 3 has an inner diameter d3 that issimilar to and just slightly larger than the outer diameter of thecartridge reservoir 7, and hence such as to enable the reservoir 7 to beinserted without any particular interference or friction.

Preferably, the housing portion 3 of the main body 2 has retaining means9 on the interior walls such as to create a reversible locking with thecartridge reservoir 7. This is an effective solution to enable thereservoir 7 to be held stably in a position of partial extraction fromthe housing portion 3 (as shown in FIGS. 1A, 1B), suitable for beingmaintained throughout the duration of storage of the device 1, prior toactual use, in a storage facility or in the compartments that mobilefirst aid vehicles are fitted with.

The retaining means 9 maintain the reservoir 7 in a non-operationalposition, and hence the device 1 in a non-activated configuration.

Preferably, the aforesaid retaining means 9 are formed with one orpreferably two annular projections positioned on the interior wall ofthe housing portion 3, in proximity to the delivery portion 5.

In this manner, the double ring formed by the retaining means 9 preventsboth the reservoir 7 from being slipped out of the housing portion 3involuntarily and the device 1 from being accidentally activated as aresult of the reservoir 7 being slid all the way down to the base 13.

In detail, the housing portion 3 extends longitudinally for a lengthcomprised between 50 mm and 200 mm, preferably comprised between 70 and150 mm.

Advantageously, at the end which is completely inserted inside thehousing portion 3, the reservoir 7 has a flange-shaped edge 7 b having aradial extent equal to the size of an inner diameter d3 of the housingportion 3.

The shaped edge 7 b is reversibly engageable, by pushing, with theaforesaid retaining means 9, which are shaped, as said, like one or moreannular projections on the interior surface of the housing portion 3.

The position of partial insertion of the reservoir 7 into the housingportion 3, and hence the non-operational condition of the device 1, isdefined by the engagement of the shaped edge 7 b with the annularretaining means 9. In such a condition, in fact, the perforating element8 is disengaged from the reservoir 7.

Once the device is activated, on the other hand, the flange-shaped edge7 b comes up against the base 13 of the perforating element 8.

Other forms of the above-described retaining means 9 are in any casepossible, though not illustrated, and fall within the scope of the samefunctional concept.

To activate the device and thus obtain the perforation of the reservoirby the perforating element 8, manual pressure must be exerted on thereservoir 7; this force causes the disengagement of the shaped edge 7 bfrom the retaining means 9 on the interior wall of the housing portion 3and thus permits the reservoir to slide further toward the base 13.During this sliding, the openable end 7 a of the reservoir 7 meets theperforating element 8, which, following a more intense and prolongedaction of pressing, tears open the openable end 7 a, placing thereservoir in fluid communication with the delivery portion 5 by means ofthe cylindrical conduit 12.

The delivery portion 5 represents the interface part of the device 1,through which the medical liquid 100 is applied by means of a pad 10which is an integral part of the delivery portion 5.

Advantageously, the pad 10 is made of a porous and/or spongy material.In particular, the porous or spongy material is such as to have at leasta structure with pockets or internal cavities open toward the outside200 and communicating with one another, and is suitable for beingimpregnated with a liquid, such as the medical liquid 100 and, in thecase concerned, for releasing it onto a patient's skin.

Preferably, the material the pad 10 is made of can be of a plastic type,made with natural materials or ones obtained by means of specificchemical processes, and it can have a soft consistency, or else be rigidand non-deformable.

In a first embodiment illustrated in FIGS. 1A, 1B, 2A, 2B, 3, 4, 5A and5B, the pad 10 is housed in a seat 17 of the delivery portion 5 designedto hold it in place by means of gluing or electric welding or else bypenetration of a certain number of elements with a pointed shape intothe material of the pad 10 so as to provide an interlock.

The housing seat 17 for the pad 10 can be defined by a flanged base 15,preferably projecting from the second open end 6 of the main body 2, andhave a circular, rectangular, square or polygonal shape; therefore, thebase 15 has a larger diameter or size than the diameter or cross sectionof the main body 2, as illustrated in FIGS. 1A, 1B, 2A, 2B, 3, 4.Alternatively, as illustrated in FIGS. 5A and 5B, the seat 17 can bedefined by an extension 18 of the side walls of the main body 2 beyondthe base 13 (FIGS. 5A and 5B).

In the first case, the housing seat 17 for the pad 10 is defined by theflanged base 15, which may be endowed with a perimeter shoulder 16, andby the base 13 (FIGS. 1A, 1B, 2A, 2B, 3, 4), and in the second case itis defined again by the base 13 and the extension 18 of the side wallsof the housing portion 3 (FIGS. 5A, 5B).

In accordance with these two configurations, the pad 10 isadvantageously cylindrical in shape and has the same section area as thedelivery portion 5 with which it is stably associated and, inparticular, the seat 17: therefore, the pad 10 has a circular,rectangular, square or polygonal cross section, with base surfaces 10 aand 10 b which are preferably flat and parallel to each other, as shownin FIGS. 1A, 1B, 2A, 2B, 3, 4, or inclined, as can be seen in FIGS. 5Aand 5B.

Though not expressly illustrated, the device according to the firstconfiguration (shown in FIGS. 1A, 1B, 2A, 2B, 3, 4) can also haveassociated with it a pad having the base surfaces 10 a and 10 b inclinedrelative to each other and, vice versa, the device in accordance withthe second configuration (illustrated in FIGS. 5A and 5B) can haveassociated with it a pad having the base surfaces 10 a and 10 b parallelto each other.

Another unillustrated embodiment envisages the flanged base 15 which isinclined relative to the axis X so as to orient the pad with the basesurfaces 10 a and 10 b in an inclined position relative to the same axisX. Having the base surface 10 a exposed to the outside environment 200in an inclined position relative to the device's axis of extension X canfacilitate its use and ease of handling, given that this is the surfacewhich is mostly in contact with the skin.

Based on what was previously affirmed, therefore, the device 1advantageously envisages the orientation of the pad 10 in the deliveryportion 5 according to different embodiments, not completely illustratedin the appended figures. In particular, the pad 10 can take on a flatconfiguration of the base surfaces 10 a, 10 b with an angle β relativeto the longitudinal axis X comprised between 90° and 30°. In theembodiment illustrated in the appended FIGS. 1A, 1B, 2A, 2B, 3, 4 theangle is 90°, i.e. the base surfaces 10 a and 10 b are both orthogonalto the axis X.

In the embodiment illustrated in FIGS. 5A and 5B, only the upper basesurface 10 a is inclined relative to the axis X, whereas the basesurface 10 b is orthogonal to the axis X.

A third embodiment, not illustrated, envisages that the two basesurfaces 10 a and 10 b are parallel to each other but both inclinedrelative to the axis X as a result of the inclination of the flangedbase 15 relative to the axis X. FIGS. 6A and 6B represent a furtherembodiment: the delivery portion 5 is defined by the same extension 18of the side walls of the housing portion 3, but unlike in theconfiguration illustrated in FIGS. 5A and 5B, the two extensions do notsurround the pad 10 but are rather embedded within it.

In detail, the extension 18 of the side walls of the main body 2 iscoated with glue, rested upon the base surface 10 b of a pad 10originally having a cylindrical shape with the base walls 10 a and 10 bparallel to each other and then pushed inside the pad 10. This pressurecauses the base surface 10 b to collapse, draws the side walls of thepad 10 toward the exterior walls of the main body 2 and causes it totake on the shape illustrated in FIGS. 6A and 6B. The free base surface10 a becomes slightly curved, taking on a convex shape.

This configuration is advantageous for several reasons; in fact, giventhe absence of the flanged base 15, a smaller quantity of plasticmaterial is required, there is no portion of plastic that can come intocontact with the skin since it is the pad that surrounds the main bodyand not vice-versa, and, moreover, there is a larger exposed surface ofthe pad available for applying the liquid, as not only the base surface10 a but also the side walls of the pad can be easily used.

Advantageously, the delivery portion 5 also has an air chamber 11interposed between the perforating element 8 and the pad 10.

The air chamber 11 has a smaller diameter than the pad 10, preferablyequal to the size of the inner diameter d3 of the housing portion 3 ofthe cylindrical body 2, and a height or depth preferably equal to orless than the inner diameter d4 of the cylindrical conduit 12 of theperforating element 8. Advantageously, the height of the air chamber 11is equal to at least one third of the inner diameter d4, preferablyequal to half of the diameter d4.

The air chamber permits part of the liquid to be accumulated in order tobetter impregnate the pad and enable good drainage and an effectivedelivery of the liquid. In order to render the drainage of the medicalsubstance on the pad more rapid and immediate, based on thephysicochemical characteristics of the medical substance applied, theair chamber can be expanded through an additional volume of air obtainedinside the pad 10, in particular by means of a cavity, not illustrated,fashioned in the base surface 10 b, and adjacent to the air chamber 11.

In order to better understand the geometric and dimensionalrelationships of these elements, the features of the cylindrical conduit12 will be described in detail below.

With reference to the reservoir 7, it has a cylindrical shape, with across section equal to that of the housing portion 3, and is preferablycircular for the whole of its extent in order to be inserted inside thelatter.

The preferred conformation, illustrated in the appended figures, showsthe reservoir having a cylindrical shape with a circular cross sectionand an inner diameter d2 comprised between 10 and 20 mm

Preferably, the reservoir 7 has the aforesaid openable end 7 a as wideas the inner diameter d2 of the reservoir 7 and sealed by a protectivefilm so as to preserve the liquid 100 by isolating it from the outsideenvironment 200.

Preferably, said film can be glued or heat-welded along theflange-shaped edge 7 b, and consists of a plastic polymer (by way ofexample: PE, PP, HDPE, LDPP) or a plastic polymer film bonded with ametal film, preferably aluminium.

Preferably, according to the preferred embodiment, the cartridgereservoir 7 has an internal capacity in terms of volume comprisedbetween 1 and 100 ml, preferably between 2 and 50 ml.

Other capacity values of the reservoir 7 and hence of the outerdimensions thereof, as well as the inner diameter d2, can in any case beenvisaged within the technical field of use of the present invention,giving rise to further and different embodiments, not illustrated in theappended figures, of the device 1.

Preferably, on the end that remains outside the housing body 3, and thusopposite the openable end 7 a, the reservoir 7 can have an annular edgesuch as to create a supporting base capable of keeping the device 1 inan upright position, for example both during storage and in anoperational condition of use of the same. An upright position means thatthe axis X is disposed vertically, the pad 10 of the device 1 is turnedupward and the supporting base of the reservoir 7 is in contact with aflat surface.

The slant of the cylindrical conduit 12 which derives from the cuttingedge 14 defines two distinct values of the height of the wall 12 arelative to the base 13—a lesser h1 and a greater h2—when measured inthe direction of the longitudinal axis X.

Preferably, the greater value of the second height h2 of the wall 12 ais equal to at least al 70% of the inner diameter d4 of the cylindricalconduit 12.

Preferably, the lesser value of the first height h1 of the wall 12 a isequal to at least 50% of the inner diameter d4 of the cylindricalconduit 12.

In this manner, the border of the openable end 7 a, which is torn andremains inside the reservoir 7 constrained to the flange-shaped edge 7b, will not risk obstructing the cylindrical conduit 12 when the deviceis in use. Other inclinations of the cutting edge 14 can give rise todifferent wall shapes and heights, variants which are not illustrated inthe appended figures but fall within the scope of the same functionalconcept.

Advantageously, as has been noted, the cylindrical conduit 12 of theperforating element 8 enables the housing portion 3 to be placed influid communication 100 with the delivery portion 5.

Advantageously, in greater detail, the cylindrical conduit 12 of theperforating element 8 enables the internal volume of the reservoir 7 tobe placed in fluid communication 100 with the pad 8 after the sealingcap placed on the openable end 7 a of the reservoir 7 has been broken.

In fact, the perforating element 8, in this case the cutting edge 14thus configured, provides a slant that enables the film present on theopenable end 7 a to be perforated and torn open progressively andgradually in a much faster and precise manner.

As can be seen in the appended figures, the outer diameter d1 of thecylindrical conduit 12 is such as to be smaller than the inner diameterd2 of the reservoir 7; in this manner the penetration of the cuttingedge 14 through the openable end 7 a, sealed by the protective filmdescribed above, can be carried out perfectly.

The outer diameter d1 of the perforating element 8 is preferablycomprised between 50% and 80%, more preferably between 60% and 70%, ofthe inner diameter d2 of the reservoir 7. In this manner, the ratiobetween the diameters and the liquid drainage space enable an outflowwith a calibrated dosage.

In one embodiment in which the volume of the reservoir is 12 ml and thediameter of the cylindrical conduit 12 is equal to 8 mm, a substantiallycomplete outflow is obtained in a period of time of between 2 and 5seconds, preferably about 3 seconds.

Advantageously, in this time of outflow of the liquid 100, the pad 10has immediately been impregnated with the pre-established optimalquantity, unlike what can be found in the prior art.

In detail, the operation of the device 1, in an operational condition ofuse—in particular of activation of the device 1—requires healthpersonnel to press the cartridge reservoir 7 (already preloaded in thedevice and held in position by means of the reversible locking describedabove) from the pre-established rest position all the way down into theactivation position with one hand, while gripping the device 1 by meansof the main body 2 with the other hand.

In other words, the manual action of health personnel moves thereservoir 7 from the reversible locking position into the activationposition, until the shaped edge 7 b comes up against the base 13 of theperforating element 8.

It is evident that the operation of activating the device 1 with themethods described above is simple, delivery is fast and the applicationtakes place under complete asepsis unlike in the prior art: in fact, thecutting edge 14 tears open the film of the openable end 7 a of thereservoir 7 a in a clean and precise manner.

Advantageously, the cylindrical conduit 12 of the perforating element 8is of a form that does not obstruct the outflow of the liquid, butrather promotes it and conveys it directly toward the pad 10 without anydispersion at the sides.

Advantageously, in greater detail, the shape of the cutting edge 14 issuch as to move the cut film border without creating any loose fragmentsof the same, which could for example obstruct the outflow of the medicalliquid 100 through the cylindrical conduit 12.

In fact, once the device 1 has been activated by health personnel, theonly passage of the liquid 100 between the housing portion 3 and thedelivery portion 5, or even better, between the reservoir 7 and the pad10, takes place exclusively by means of the cylindrical conduit 12.

Advantageously, in the device 1 when activated, the position of theshaped edge 7 b together with the base 13 of the perforating element 8ensures a hermetical seal for the medical liquid 100.

In this state of the device 1, involuntary leaks or dispersions of themedical liquid 100 no longer occur, as is probable, in contrast,according to the prior art.

Advantageously, with the hermetic seal formed between the shaped edge 7b and the annular base 13, the device 1 can be easily used by healthpersonnel in any preferred position: vertical, with the pad 10 turned upor with the pad 10 turned down, or else in a horizontal position or inany intermediate position between them.

The perforating element 8 can be configured so as to accommodate withinit a colouring substance that reacts chemically with the medical liquid100 only at the moment of activation of the device 1: in this manner themedical liquid 100 will be clearly evident during the applicationthereof, preventing health personnel from leaving portions of thepatient's skin untreated. The substance is closed inside the cylindricalconduit 12 by a membrane that is soluble on contact with the medicalliquid or can be impregnated in a pad situated inside the air chamber 11or in the cylindrical conduit 12 or dispersed in the cavity of the pad.

A further distinctive feature of the device 1 is the fact that thecylindrical conduit 12 is the only element that regulates the outflow ofthe medical liquid 100 during the activation of the device 1 andsubsequently during the application of the liquid 100 on the patient'sskin.

Advantageously, the variation, on each occasion, of the inner diameterd4 of the cylindrical conduit 12 according to the differentconfigurations of the perforating element 8, enables an outflow at acalibrated dosage in terms of flow rate (i.e. ml/sec), based on eachtype of medical liquid 100 delivered into the pad 10.

Advantageously, with this outflow rate of the liquid 100 the pad 10 isevenly impregnated with the optimal pre-established quantity, unlikewhat may be found in the prior art.

Advantageously, the air chamber 11 present between the pad 10 and theperforating element 8 is such as to favour and considerably improve thesystem of channelling the medical liquid 100, contributing to the rapiddischarge of the liquid without there being any need for furtheroperations on the part of health personnel during use, for examplepatting or dabbing the material of the pad 10 in order to activateand/or speed up the impregnation thereof.

Advantageously, other medical liquids can be used with the presentdevice 1, by suitably calibrating the inner diameter d1 of thecylindrical conduit 12. It is evident that the inner diameter d1 of thecylindrical conduit 12 is an important calibration parameter, in termsof both time (seconds) and flow rate (ml/s), for optimal delivery of themedical liquid 100 achieved by means of the device 1 of the presentinvention.

Advantageously, the calibration of the inner diameter d4 makes itpossible to obtain a better outflow of the liquid 100 and betterapplication of the same in terms of time and flow rate.

This result is achieved by the device 1 independently of thecharacteristics of the medical liquid 100 used, whether they are alcoholbased or contain surfactants; preferably, to ensure a better and furthereffectiveness of the device 1, the medical liquid 100 should have asurface tension of less than 72.80 mN/m and preferably around 23 mN/m.

Advantageously, the perforating element 8 can be made in one piece withthe main body 2 or else it can be made separately and inserted into themain body 2 during assembly with a pre-established interference thatensures a hermetic seal of the coupling between the element 8 andinterior walls of the body 2.

This aspect makes it possible, advantageously, to have the perforatingbody 8 made of a different material than the other elements of thedevice 1 (for example the body 2 and the reservoir 7); by way ofexample, it can be made of a plastic or metallic material, or can haveportions made of different materials.

It is evident that the combination of different sizes of the outerdiameter d1 of the cylindrical conduit 12 and of the cutting edge 14 ofthe perforating element 8, as well as of the inner diameter d2 of thereservoir 7 and obviously the inner diameter d3 of the main body 2 whichhouses both elements (reservoir 7 and perforating element 8), producesdifferent configurations of the aforesaid elements and also differentembodiments of the entire device 1.

Only one possible preferred, but not exclusive, embodiment of the device1, was illustrated deliberately.

Advantageously, all of the elements making up the device 1 can be madewith materials compatible with the traditional sterilization techniquesused in the medical realm (by way of example: a gas with ethylene oxide,or with “Beta” or “Gamma” rays).

Preferably, the device 1 can be made completely of, or one of its mainelements can be made of a plastic material such as PP, PE or HDPE orother non-plastic materials.

In this regard, advantageously, the device 1 is capable of ensuringmaximum levels of asepsis by means of a protective film appliedpreferably at the end of the process of production of the device 1;preferably the covering is a heat-shrinkable film that completelyenvelops the device 1.

The peculiarity of the numerous angular variants in the position of thepad 10 relative to the axis X of the main body 2 permits a better, moreeffective use of the device 1 itself, maximizing the distribution of themedical liquid 100 on the patient's skin without leaks or involuntarydripping, which may sometimes be dangerous.

The hollow structure of the perforating element 8 of the device 1described no longer consists of a central perforating tip withperipheral outflow channels as in the prior art, but is rather anelement of control and dosage assuring that the outflow itself iscalibrated based on a quantity that is pre-established on each occasion.

Advantageously, overall the device 1 enables a more rapid, effective andprecise use, facilitating the work of personnel assigned to provideemergency aid, where time and effectiveness of action are of fundamentalimportance.

The invention claimed is:
 1. A device (1) for the application of liquidmedical substances (100), comprising: a main body (2) extending around alongitudinal axis (X) and comprising a housing portion (3) and adelivery portion (5); a cartridge reservoir (7) containing a liquidmedical substance (100), hermetically sealed and suitable for beinginserted into said housing portion (3); a perforating element (8)disposed inside said main body (2) in a position falling between saidhousing portion (3) and said delivery portion (5) in order to achievethe perforation of one end of said cartridge reservoir (7); saidperforating element (8) having a tubular shape and comprising inside thetubular shape a cylindrical conduit (12) having a cutting edge (14)faced toward the housing portion (3), wherein said conduit (12) servesto place said housing portion (3) in fluid communication with saiddelivery portion (5), characterized in that said perforating element(8), presenting at an end opposite the cutting edge (14) a flanged base(13) for connecting with said main body (2), has a first height (h1),defined between the lowest point of said cutting edge (14) and said base(13), not less than 50% of an inner diameter (d4) of the cylindricalconduit (12), and a second height (h2), defined between the highestpoint of said cutting edge (14) and said base (13), not less than 70% ofthe inner diameter (d4) of the cylindrical conduit (12).
 2. The device(1) according to claim 1, characterized in that said cutting edge (14)of said perforating element (8) is inclined, relative to saidlongitudinal axis (X), by an angle (α) comprised between 30° and 60°;said cutting edge (14) extending along a closed line delimiting saidconduit (12).
 3. The device (1) according to claim 1, characterized inthat said perforating element (8) has a cylindrical shape and is coaxialwith said longitudinal axis (X).
 4. The device (1) according to claim 1,characterized in that said cylindrical conduit (12) of the perforatingelement (8) has an outer diameter (d1) that is smaller than an innerdiameter (d2) of the cartridge reservoir (7); said outer diameter (d1)of the cylindrical conduit (12) being comprised between 50% and 80% ofthe inner diameter (d2) of the cartridge reservoir (7).
 5. The device(1) according to claim 1, wherein said cartridge reservoir (7) has oneend (7 a) designed to be perforated by said perforating element (8) andhermetically sealed with a film or heat-shrink film made of a plasticand/or metallic material.
 6. The device (1) according to claim 1,characterized in that said cartridge reservoir (7) has an internalvolume capacity comprised between 1 and 100 ml.
 7. The device (1)according to claim 1, characterized in that on the interior surface ofsaid housing portion (3), said main body (2) has retaining means (9) forkeeping the reservoir (7) stably in a position of partial insertion intothe housing portion (3); said position of partial insertion into thehousing portion (3) defining a situation of disengagement between theperforating element (8) and reservoir (7).
 8. The device (1) accordingto claim 7, wherein said cartridge reservoir (7) has a flange-shapededge (7 b) disposed at an openable end (7 a) and engageable with saidretaining means (9); said flanged edge (7 b) having a radial extentsubstantially equal to an internal dimension (d3) of the housing portion(3).
 9. The device (1) according to claim 1, wherein said deliveryportion (5) comprises a pad (10) made of a material with a porousstructure, so as to be impregnated by the medical liquid (100) deliveredfrom said reservoir (7) through the cylindrical conduit (12), which,when the device is in use, places said reservoir (7) in fluidcommunication with said pad (10).
 10. The device (1) according to claim9, characterized in that said delivery portion (5) comprises an airchamber (11) included between said pad (10) and said perforating element(8); said air chamber (11) having a height equal to at least one thirdof the inner diameter (d4).
 11. The device (1) according to claim 9,wherein said pad (10) has base surfaces (10 a, 10 b) disposed accordingto an angle (β) comprised between 90° and 30° relative to saidlongitudinal axis (X).
 12. The device according to claim 9,characterized in that said pad (10) is inserted into a housing seat (17)present at one end (6) of the main body (2) or surrounds said end (6) ofthe main body (2).
 13. The device (1) according to claim 11, wherein acolouring substance for said medical liquid (100) is contained in saidperforating element (8) or in an air chamber (11) so as to be released,following the penetration of said cutting edge (14) through an openableend (7 a) of the cartridge reservoir (7), into said medical liquid inorder to make the release thereof evident during use of the device. 14.The device (1) according to claim 1, characterized in that said cuttingedge (14) of said perforating element (8) is inclined, relative to saidlongitudinal axis (X), by an angle (α) of 45°; said cutting edge (14)extending along a closed line delimiting said conduit (12).
 15. Thedevice (1) according to claim 1, characterized in that said cylindricalconduit (12) of the perforating element (8) has an outer diameter (d1)that is smaller than an inner diameter (d2) of the cartridge reservoir(7); said outer diameter (d1) of the cylindrical conduit (12) beingcomprised between 60% and 70% of the inner diameter (d2) of thecartridge reservoir (7).
 16. The device (1) according to claim 1,wherein said cartridge reservoir (7) has one end (7 a) designed to beperforated by said perforating element (8) and hermetically sealed witha plastic film bonded with an aluminum film.
 17. The device (1)according to claim 1, characterized in that said cartridge reservoir (7)has an internal volume capacity comprised between 2 and 50 ml.
 18. Thedevice (1) according to claim 9, characterized in that said deliveryportion (5) comprises an air chamber (11) included between said pad (10)and said perforating element (8); said air chamber (11) having a heightequal to at least one half of the inner diameter (d4) of saidcylindrical conduit (12).